Loperamide Hydrochloride
- Product NDC
- 60468-005
- 11-digit product format
- 604680005
- Labeler code
- 60468
- Product ID
- 60468-005_f54d6351-da06-808b-e053-2a95a90ae4cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- allphamed Pharbil Arzneimittel GmbH
- Application
- ANDA215001
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loperamide Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60468-005-01 | Loperamide Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 60468-005-05 | Loperamide Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 60468-005-30 | Loperamide Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60468-005 | LOPERAMIDE HYDROCHLORIDE CAPSULE [ALLPHAMED PHARBIL ARZNEIMITTEL GMBH] | 1 | Current NDC, 3 package rows | 20230223_a8c8d1d2-a8c7-462a-b620-729a9baa93c4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60468-005-01 | 60468000501 | 100 CAPSULE in 1 BOTTLE (60468-005-01) | 100 capsule | 2020-09-25 | No | No | Current |
| 60468-005-05 | 60468000505 | 500 CAPSULE in 1 BOTTLE (60468-005-05) | 500 capsule | 2020-09-25 | No | No | Current |
| 60468-005-30 | 60468000530 | 30 CAPSULE in 1 BOTTLE (60468-005-30) | 30 capsule | 2020-09-25 | No | No | Current |